MedTrace Logo

Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent to Prevent Post-Operative Complications

NCT02812199 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-05-02

No results posted yet for this study

Summary

This is a randomized controlled first in man study. Study purpose is to assess safety and efficacy of Composite Removable Stent Composite Stent implantation post-endoscopic sinus surgery in terms of:

* Sinus tissue adhesions
* Middle turbinate lateralization into nasal septum i.e. postoperative opening reduction
* Inflammation

Conditions

  • Chronic Sinusitis

Interventions

DEVICE

Composite Removable Sinus Stent

Post-FESS bilateral implantation of sinus stent into middle meatus. Nasal tampon will be placed to stop bleeding. Stent will be removed after 14 - 28-day implantation, during self-crimp procedure induced by cold saline flush and safely pulled out. During implantation period patients will be examined endoscopically for inflammation, adhesions and middle turbinate position.

DRUG

adrenaline-lidocaine

adrenaline - lidocaine administration to minimize bleeding prior to stent removal (group 1 and group 2)

PROCEDURE

cold saline wash

nasal wash with cold saline prior to stent removal, to induce stent self-crimping.

Sponsors & Collaborators

  • STS Medical

    lead INDUSTRY

Principal Investigators

  • Eitan Yaniv, Prof · ENT Surgeon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02812199 on ClinicalTrials.gov